Adamis Pharmaceuticals completes PK studies comparing ZIMHI to generic
Adamis Pharmaceuticals Corporation announced the completion of pharmacokinetic studies comparing its naloxone injection product candidate, ZIMHI Injection, to a generic naloxone comparator. In June, the Company amended the New Drug Application for ZIMHI to remove any reference to EVZIO and withdrew the Paragraph IV certification relating to that product. On August 8, the Company announced it was conducting additional PK studies comparing ZIMHI and a relevant comparator. The data for the PK study has been recorded and is complete. The data base will be forwarded to the FDA this month. As previously announced, the PDUFA date remains October 31, 2019.